510(k) · Cleared
ClearedCeribell Infant Seizure Detection Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceribell, Inc. · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on Nov 21, 2025 as substantially equivalent to K241589 (Ceribell, Inc., 2025) after a 143-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Nov 21, 2025
- Review
- 143 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K830295 (1983). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 3 generations backK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- 2 generations backK191301 Ceribell Pocket EEG DeviceCeribell, Inc. · 2019
- 1 generation backK241589 Ceribell Seizure Detection SoftwareCeribell, Inc. · 2025
- This deviceK252070 Ceribell Infant Seizure Detection SoftwareCeribell, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −3 | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| −2 | K191301 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2019 | — |
| −1 | K241589 | Ceribell Seizure Detection Software | Ceribell, Inc. | 2025 | — |
| 0 (this device) | K252070 | Ceribell Infant Seizure Detection Software | Ceribell, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OMB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OMB device
- #1 K240993 encevis (2.1)score 15.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K241589 | Ceribell Seizure Detection SoftwareSummary page 5…Electroencephalograph (21 CFR 882.1400) Device Class: II Product Code: OMB 3. PREDICATE DEVICE Ceribell Seizure Detection Software, K241589 4. DEVICE DESCRIPTION The Ceribell Infant Seizure Detection Software is a software-only device that is intended to mark previo… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 42 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All OMB devicesOMB Automatic Event Detection Software For Full-Montage Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OMB
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMB
143in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMB
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMB
6in 2025
MAUDE reports naming product code OMB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 3 | 233 | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 108 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 5 | 201 | 0 | 21 |
| 2025 | 5 | 143 | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Ceribell Infant Seizure Detection Software is intended to mark previously acquired sections of EEG recordings in newborns (defined as preterm or term neonates of 25-44 weeks postmenstrual age) and infants less than 1 year of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection Software also provides notifications to the user when detected seizure…
Read the full statement (150 words)
The Ceribell Infant Seizure Detection Software is intended to mark previously acquired sections of EEG recordings in
newborns (defined as preterm or term neonates of 25-44 weeks postmenstrual age) and infants less than 1 year of age that
may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG
traces. The Seizure Detection Software also provides notifications to the user when detected seizure prevalence is
“Frequent”, “Abundant”, or “Continuous”, per the definitions of the American Clinical Neurophysiology Society
Guideline 14. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure
Detection notifications will be shown to a user.
The Ceribell Infant Seizure Detection Software does not provide any diagnostic conclusion about the subject’s condition
and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a
trained expert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252070 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252070: Ceribell Infant Seizure Detection Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252070
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026